MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT PS CEM FEM PS CEM LEFT SZ 4

Model Number	02-020-11-0240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: size 4, 11mm tibial insert (cn: 02-022-35-4011, sn: (b)(4)); size 4f/3t tibial tray (cn: 02-022-45-4030, sn: (b)(4)); 32mm patella (cn: 200-02-32, sn: (b)(4)).
Event or Problem Description
As reported approximately 14 months postoperative initial left tka this (b)(6) y/o female patient¿s knee was determined to have a failed component.The surgeon opened the joint in standard fashion and decided to take everything out and implanted a competitor¿s tka.The joint was closed in standard fashion.Patient was last known to be in stable condition following the event.Devices not returning due to hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that upon review of all available information, the revision reported in this event was likely the result of failure of the cement mantle between the implant and the bone which led to aseptic (non-infected) loosening of the tibial component.Section (d10) concomitant devices: - size 4, 11mm tibial insert (cn: 02-022-35-4011, sn: (b)(6) - size 4f/3t tibial tray (cn: 02-022-45-4030, sn: (b)(6) - 32mm patella (cn: 200-02-32, sn: (b)(6) section(s): no information has been provided: a4, a5, b6, the following section(s) have additional info: d10, g4, g7, h1, h2, h3, and h7.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9780621
• Report Number: 1038671-2020-00238
• Device Sequence Number: 16313416
• Product Code: JWH
• UDI-Device Identifier: 10885862314451
• UDI-Public: 10885862314451
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02-020-11-0240
• Device Catalogue Number: 02-020-11-0240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR